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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN 3000 PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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CODMAN 3000 PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 04/30/2017
Event Type  Injury  
Manufacturer Narrative
Unknown product code, udi unavailable.It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
 
Event Description
As reported by a patient, after 12 years a codman 3000 pump is not working properly and the patient is experiencing withdrawal symptoms.Patient wants information concerning replacement.The doctor wrote in the notes the pump is nonfunctional.There is no plan to remove the pump at this time.The patient did present with some withdrawal symptoms and was given oral and transdermal medication which is being continued at this time.
 
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Brand Name
CODMAN 3000 PUMP
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6842145
MDR Text Key84721319
Report Number1226348-2017-10660
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/17/2017
Initial Date FDA Received09/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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